N/A
N=18
Effects of Reading to Preterm Infants on Baby and Parents' Well Being
Parental Infant Bonding · Cardio-respiratory Stability in Preterm NICU Infants
Bottom Line
View on ClinicalTrials.gov: NCT02518997 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Percent of Oxygen Saturation Measurements <85% — 15.2; 16.94; 17.65; 14.39 Percent Oxygen saturation measurements
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Parental Reading Aloud (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Georgetown University
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Oxygen Saturation Measurements <85% |
15.2; 16.94; 17.65; 14.39 | — |
Summary
Reading to children is believed to be beneficial to cognitive and mental development.This study will examine the response of premature Neonatal Intensive Care Unit (NICU) infants to bedside reading by measuring changes in heart rate, blood pressure, breathing and oxygen levels. The investigators will follow rates of common preterm health issues while in the hospital and time to hospital discharge. Effects of bedside reading on parental stress and infant bonding will be measured and compared to usual rates of these indicators to determine if reading to babies reduces stress and enhances bonding.
Eligibility Criteria
Inclusion Criteria
- Infants between 26 0/7 34 6/7 weeks corrected gestational age (CGA) at the time of enrollment, [gestational age stated as # of weeks plus the number of days of the next week completed, the days are expressed as a fraction of a 7 day week (CGA= GA at birth + days of life)] rationale: 26 0/7 is the age at which the auditory system is generally well formed but still immature. Infants born at less than 26 0/7 weeks GA can be enrolled once they reach 26 0/7 weeks.
- Infants at least 7 days of life to allow for transition to extrauterine life.
Parental Inclusion Criteria
- Agreement to the study with signed Informed Consent Form and HIPAA Authorization
- Visits on a regular basis (at least 3 times per week)
- Is literate (able to read)
Exclusion Criteria
- Infants deemed too ill to participate by the primary care team at one week of age, although those infants may be enrolled at a later date when they are stabilized with the approval of the clinical care team,
- infants with congenital hearing loss,
- chromosomal abnormalities,
- infants not expected to survive.
Parents Exclusions Does not read or is uncomfortable reading aloud. (unlikely to sign informed consent if this is the case)
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Data sourced from ClinicalTrials.gov (NCT02518997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.